Effects of Hydroxytyrosol on Vascular Health
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Mayo Clinic
- Locations
- 2
- Primary Endpoint
- Surrogate markers
Study Overview
Brief Summary
The purpose of this study is to conduct a double-blind, randomized controlled trial (RCT), to determine if six month supplementation of olive oil can improve the health of the blood vessels and improve long term health of the heart and blood vessels, in patients requiring percutaneous coronary intervention (PCI).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Surrogate markers
Time Frame: 6 months
In order to address these hypotheses, our specific aims are to investigate the effect of administration of six months of hydroxytyrosol in individuals with multiple cardiovascular risk factors and with known coronary artery disease, on: Improvement and normalization of surrogate markers of CVD such as leukocytes, glucose, lipids, renal function, and high-sensitivity C-reactive protein (hs-CRP).
Endothelial function
Time Frame: 6 months
In order to address these hypotheses, our specific aims are to investigate the effect of administration of six months of hydroxytyrosol in individuals with multiple cardiovascular risk factors and with known coronary artery disease, on: Improvement of endothelial function as determined by peripheral endothelial function testing and circulating EPCs.
Secondary Outcomes
No secondary outcomes reported
Investigators
Amir Lerman
Invasive Cardiologist, Professor of Medicine
Mayo Clinic